West Pharma Engineering Lab Manager R&D 

United States, Nebraska 

974332926

This Full-time onsite role will be supervising, coordinating and administering the site Quality Control systems compliance: Document Control, Nonconformance/ Deviation Reports, OOS Process, Measurement Systems, Change Control, Calibration and CAPA’s. Supervise and support internal projects and ensure cGMP compliance, applicable ISO requirements, company policies and procedures.

• Qualify inspectors to independently perform responsibilities for competency/ proficiency capabilities in inspections, measurements, sampling, Quality audits and defect recognition.
• Qualify and/or support qualification of team members for competency/proficiency in defect and quality incident recognition/escalation.
• Train inspectors in deviation/non-conformance/OOS record initiations, escalations, how to perform containment/bracketing, and initial event triage activities.
• Ensure deviation/ nonconformance reports and OOS’s are completed properly, including root cause investigation (if required), effective corrections and actions closed within an established goal.
• Monitor and enforce compliance to a high level of work standards across the QC functions. Ensure that jobs are carried out efficiently. Paperwork is maintained accurately in accordance with Company policies, Regulatory standards and Training.
• Perform various SAP transactions for maintaining proper product disposition for release criteria and inventory control.
• Analyze data and provide reports/ recommendations to Management for continuous improvement.
• Submit periodic reports on the status of compliance to Quality System requirements.
• Review Customer specifications and ensure requirements are translated into site procedures and documentation as needed.
• Provide for Quality planning by preparing inspection plans and documentation controls.
• Support facilities, equipment and process validations. Approve engineering studies and other protocols as required.
• Ensure proper completion of Change Controls and monitor timely completion when required.
• Monitor completion of MSA’s for critical measurement systems and provide recommendations for gauging improvements.
• Provide expertise and guidance for statistical methods in Production.
• Conforms with and abides by all regulations, policies, work procedures, instructions and all safety rules.
• Performs other duties as assigned based on business needs.
• Exhibits regular, reliable, punctual and predictable attendance.
• Other duties as assigned

• Highschool Diploma required.
• Bachelor's degree in Quality, Engineering, Science or equivalent experience preferred.

• Minimum of 3 years of related experience analyzing information, documentation skills, promoting process improvement and safety management.
• Minimum 1 year of leadership experience or demonstration of leadership skills routinely as part of previous/current role(s)

• Demonstrate a high degree of proficiency in Excel, Word and other Microsoft Office Programs required. Demonstrate oral and written communication skills.
• Familiarity with a variety of Quality concepts, practices, AQL sampling plans for attribute and dimensional inspection. Demonstrate ability to investigate problems and issues in order to determine root cause analysis.
• Familiarity with GMP/GDP Regulations
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to make independent quality decisions under pressure, if necessary
• Support and contribute in Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times

• Manufacturing environment requires strict adherence to standards. Working environment is a manufacturing facility and must be able to tolerate fumes and particulate generated from the processes.
• Work areas are equipped with adequate lighting, cooling/heating and equipment that are in a good working condition.
• Must work constructively in an environment that may have competing resources, while maintaining company confidentiality.
• Must be able to work scheduled work week, plus overtime and/or irregular hours as required to complete assignments.
• May stand or sit for extended periods of time.
• Must transport oneself to and from other areas of the facility and travel to other facilities when necessary.
• Must have good visual acuity. If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues.

• Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems
• Maintain high attention to detail, accuracy, and overall quality of work.
• Effectively communicate and interface with various levels internally and with customers.
• Able to be aware of all relevant SOPs as per Company policy and Quality Manual

1st Shift Position, with occasional adjustments to accomodate 2nd/3rd shift interactions